Randomized, Controlled Trial of Kangaroo Mother Care in Increasing the Rate of Weight Gain Among Neonates

Phase 3

Completed

• Conditions: Low Birth Weight Among Neonates

• Registration Number: NCT02085382
• Lead Sponsor: University of the Philippines

Brief Summary

A randomized, controlled trial of Kangaroo Mother Care (KMC) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.

Detailed Description

A randomized, controlled trial of Kangaroo Mother Care (KMC) versus Conventional Care to determine the effectiveness of KMC in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• birth weight <1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °C),
• normal heart rate (120-160 bpm), normal blood pressure per age
• no apnea
• no intravenous lines or with well-secured peripheral line
• no sepsis
• no emerging signs of sepsis
• on IV antibiotic therapy but clinically stable
• can require photo therapy but with stable and not rising total serum bilirubin (TSB) level or TSB is not in high risk zone.

Exclusion Criteria

• neonates with chromosomal and life threatening congenital anomalies, who were severally ill
• whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low Birth Weight	3 days	Low-birth weight infants both in the intervention and control group were discharged from the study according to the following criteria: baby's general health was good as assessed by the attending physician and in evidence of infection, feeding well and receiving exclusively breast milk, gaining weight (at least 15-20 grams/kg/day for at least 3 days), maintaining body temperature satisfactorily for at least 3 consecutive days in room temperature and the mother and family members were confident to take care of the baby in KMC.

Trial Locations

Locations (1)

Philippine General Hospital - University of the Philippines Manila; 🇵🇭 Manila, National Capital Region, Philippines